Billing and Coding: Guardant360

This coverage article has been created and published for notice under contract numbers: 02101 (AK), 02201 (ID), 02301(OR), 02401 (WA), 03101 (AZ), 03201 (MT), 03301 (ND), 03401 (SD), 03501 (UT), and 03601 (WY).

Effective Date: May 15, 2020

Summary of Article: Coverage will continue on a case by case basis utilizing the following criteria until such time a more comprehensive non-proprietary local coverage determination can be developed.

Guardant360® remains covered for patients with non-CNS originated solid tumors who meet the criteria of NCD 90.2 when the following conditions are met:

Patient has been diagnosed with a recurrent, relapsed, refractory, metastatic, or advanced solid tumor that did not originate from the central nervous system. Patients who would meet all of the indications on the FDA label for larotrectinib if they are found to have an NTRK mutation may be considered to have advanced cancer, and

  • Patient has not previously been tested with the Guardant360® test for the same primary cancer. For a patient who has been tested previously using Guardant360® for a cancer, that patient may only be tested again unless when the patient has a new primary cancer diagnosis. In a patient with previously tested primary cancer, who has evidence of new malignant growth, that growth may be considered to be a different primary cancer if it does not originate from the same cell line or it is physiologically different enough that it responds differently to treatment than the previously tested cancer, and
  • Patient is untreated for the primary cancer being tested or the patient is not responding to treatment (e.g. progression or new lesions on treatment), and
  • The patient has decided to seek further cancer treatment with the following conditions:
    • The patient is a candidate for further treatment with a drug that is either FDA-approved for that patient’s cancer, or has an NCCN 1 or NCCN 2A recommendation for that patient’s cancer, and
    • The FDA-approved indication or NCCN recommendation is based upon information about the presence or absence of a genetic biomarker tested for in the Guardant360® assay, and
  • Tissue-based CGP is infeasible (i.e., quantity not sufficient for tissue-based CGP or invasive biopsy is medically contraindicated) or specifically in NSLC Tissue-based CGP has shown no actionable mutations.

If no alteration is detected by Guardant360® or if ctDNA is insufficient/not detected, tissue-based genotyping should be considered.

Visit the Noridian Medicare Coverage Articles webpage to view the complete listing of locally hosted coverage articles and/or access the Active, Future, or Retired articles available in the CMS MCD.


            Last Updated Fri, 29 May 2020 16:37:27 +0000